Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in… (NCT07654829) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
United States100 participantsStarted 2026-07-31
Plain-language summary
This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients ≥12 years of age at time of Screening
. Confirmed diagnosis of HAE Type I or II based on patient report
. Patient has a qualifying procedure that is scheduled or planned to be scheduled to occur within 8 weeks of Screening
. Patient has access to a commercial available on-demand treatment for HAE
. Female patients of childbearing potential, including post-menarchal adolescents, must meet contraception requirements per Section 11.3. (Note: male patients do not require contraception)
. Patients must be able to swallow trial tablets whole
. Patients, as assessed by the Investigator, must be able to appropriately receive and store IMP, and be able to read, understand, and complete the questionnaire
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized.
Timeframe: 24 hours following the start of the procedure
. Investigator believes that the patient is willing and able to adhere to all protocol requirements through the duration of the trial
Exclusion criteria
. A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator
. Use of angiotensin-converting enzyme (ACE) inhibitors within 7 days prior to the Screening Visit
. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit
. Patients who are taking strong cytochrome P450 (CYP)3A4 inhibitors or inducers or moderate CYP3A4 inducers within 2 weeks of the procedure
. Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial
. History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator
. Known hypersensitivity to sebetralstat or to any of the excipients
. Participation in any gene therapy treatment or trial for HAE